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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004910 |
Purpose
RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery.
PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Constipation, Impaction, and Bowel Obstruction Extrahepatic Bile Duct Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Pancreatic Cancer Quality of Life Small Intestine Cancer |
Procedure: bowel obstruction management Procedure: quality-of-life assessment |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy |
| Study Start Date: | January 2000 |
| Study Completion Date: | February 2003 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum.
Quality of life is assessed at 48 hours and 6 months after procedure.
Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Endoscopically confirmed localized tumor as the cause of duodenal obstruction
Must have symptoms of gastrointestinal obstruction, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Study Chair: | Willis G. Parsons, MD, PC | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Julie Kim, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004910 History of Changes |
| Other Study ID Numbers: | NU 98CC2, NU-98CC2, NCI-G00-1703 |
| Study First Received: | March 7, 2000 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
|
stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer recurrent colon cancer localized gastrointestinal carcinoid tumor |
regional gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor small intestine adenocarcinoma small intestine lymphoma small intestine leiomyosarcoma localized extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer recurrent small intestine cancer constipation, impaction, and bowel obstruction quality of life gastrointestinal stromal tumor stage IV pancreatic cancer |
|
Carcinoid Tumor Colorectal Neoplasms Constipation Duodenal Obstruction Intestinal Obstruction Stomach Neoplasms Pancreatic Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Bile Duct Neoplasms Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Intestinal Neoplasms |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |